Acamprosate Added to Escitalopram and Behavioral Treatment for Comorbid Depression and Alcoholism

NCT00452543 | Completed Phase 4 Results

• 1 other identifier: 2006-P-001592/1
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study about treatment for people who suffer from both major depression and alcohol abuse or dependence. The study will examine whether the addition of acamprosate to escitalopram and behavioral interventions will improve outcomes for this population.

Conditions

Major Depressive Disorder; Alcohol Abuse; Alcohol Dependence

Keywords

Major depressive disorder; Alcoholism; Alcohol abuse; Alcohol dependence

Outcome Measures

Primary Outcomes (4)

• Change in Mean Score on the Hamilton Rating Scale for Depression -- 17 Items (HAM-D-17)

  Scores on the HAM-D-17 typically fall into the following ranges: a) Not depressed: 0-7; b) Mildly depressed: 7-15; c) Moderately depressed: 15-25; d) Severely depressed: over 25. A decrease of 50% or more in the Hamilton-D score is considered to be a positive response to treatment, while a score of 7 or less is considered typical of remission. We measure the change in total score from Baseline to Week 12 or week of early termination visit.

  From baseline visit to Week 12 (or early discontinuation visit)

• Total Drinking Days on the Alcohol Timeline Followback (TLFB)

  The TLFB assesses recent drinking behavior. On the TLFB, clients retrospectively estimate their daily alcohol consumption in standard drinks over a time period ranging from 7 days to 24 months prior to the interview, and thus the measure provides quantitative estimates of alcohol use. One standard drink on the TLFB was defined as: 12 oz beer (5% alcohol by volume), 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv). We measure the change from Baseline to Week 12 or week of early termination visit.

  From Baseline visit to Week 12 (or early discontinuation visit)

• Total Drinks Consumed Per Week on the TLFB

  Total Drinks Consumed per Week on the Time Line Follow Back. We measure the change from Baseline to Week 12 or week of early termination visit.

  From Baseline visit to Week 12 (or early discontinuation visit)

• Total Drinks Consumed Per Drinking Day on the TLFB

  Total Drinks Consumed per Drinking Day on the Time Line Follow Back. We measure the change from Baseline to Week 12 or week of early termination visit.

  From Baseline visit to Week 12 (or early discontinuation visit)

Study Arms (2)

Escitalopram plus acamprosate

EXPERIMENTAL

Drug: acamprosate; Drug: escitalopram; Behavioral: Medical management

Escitalopram plus placebo

PLACEBO COMPARATOR

Drug: escitalopram; Behavioral: Medical management; Drug: Placebo

Interventions

acamprosate DRUG

Acamprosate 333mg, 2 capsules by mouth (i.e., PO), three times per day (i.e., TID), for 12 weeks.

Also known as: Campral

Escitalopram plus acamprosate

escitalopram DRUG

Escitalopram is given for 12 weeks. Dosing is flexible, starting at 10mg PO once per day (i.e., QD) with the possibility of increasing to 30mg PO QD.

Also known as: Lexapro

Escitalopram plus acamprosate; Escitalopram plus placebo

Medical management BEHAVIORAL

Based on the COMBINE study. 1 hour of medical management / behavioral intervention at every study visit (7 times over 12 weeks).

Also known as: Campral and Lexapro

Escitalopram plus acamprosate; Escitalopram plus placebo

Placebo DRUG

Placebo, 2 capsules PO TID, for 12 weeks

Also known as: Campral and Lexapro

Escitalopram plus placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• DSM-IV diagnostic criteria for MDD (diagnosis based on Structured Clinical Interview for DSM-IV, Patient Edition; SCID I/P)
• Written informed consent
• Men and women aged 18-64 years
• Current diagnosis of alcohol abuse/dependence as per SCID I/P

You may not qualify if:

• Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment.
• Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, partner with vasectomy).
• Known history of serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease.
• History of seizure disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative disease such as ALS, Parkinson disease and any movement disorders, etc.).
• Clinical or lab evidence of untreated hypothyroidism.
• History or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance use disorders (excluding alcohol and nicotine) active within the last 12 months.
• Current use of other psychotropic drugs, including current use of benzodiazepines, hypnotics, anticonvulsants. Concomitant use of antihistamine drugs will be allowed. Patients will need to be off all antidepressants for at least two weeks by the time of the baseline visit, and four weeks for fluoxetine, and off benzodiazepines and other psychotropics for at least one week. The decision about whether to taper existing medications should be made by the individual and their primary treater based on clinical care and will not be made for purposes of study enrollment. allowed.
• Patients who have failed to respond during the course of their current major depressive episode to at least two adequate antidepressant trials. An adequate antidepressant trial is defined as six weeks or more of treatment with escitalopram \> 20mg/day or its antidepressant equivalent: (fluoxetine 40mg/day, sertraline \> 100 mg/day, paroxetine \> 40 mg/day, fluvoxamine \> 100 mg/day, citalopram \> 40 mg/day, escitalopram \> 20 mg/day, venlafaxine \> 150 mg/day, and duloxetine \> 60 mg/day).
• Any depression-focused or substance-abuse focused psychotherapy (family or marital counseling would be allowed).
• Patients who have taken an investigational psychotropic drug within the past year.
• Need for medical or inpatient detoxification from alcohol. This determination will be made by the screening clinician, based on clinical judgement as in the multicenter STAR\*D study (PHRC #2000-P-001955 in accordance with methods used in the multi-center STAR-D study.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Witte J, Bentley K, Evins AE, Clain AJ, Baer L, Pedrelli P, Fava M, Mischoulon D. A randomized, controlled, pilot study of acamprosate added to escitalopram in adults with major depressive disorder and alcohol use disorder. J Clin Psychopharmacol. 2012 Dec;32(6):787-96. doi: 10.1097/JCP.0b013e3182726764.

  PMID: 23131884 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Alcoholism

Interventions

Acamprosate; Escitalopram; Practice Management, Medical

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Taurine; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Propylamines; Amines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Dr. Janet Witte
• Organization: Massachusetts General Hospital

jwitte@partners.org

617-726-5104

Study Officials

• Janet M Witte, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Nicholas Bolo, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 26, 2007
• First Posted: March 27, 2007
• Study Start: March 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 9, 2012
• Results First Posted: July 9, 2012

Record last verified: 2012-06

Locations

US (1)